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Senior Manager, Regulatory Intelligence

Employer
Regeneron Pharmaceuticals, Inc.
Location
Armonk, New York
Start date
May 2, 2024

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

This role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization. This position will also serve as a lead Reg Intel contact in support of cross-functional requests and initiatives from the Global Clinical Development organization and various functions within the organizations GxP framework.

In this role, a typical day might include:

  • Project Management and leadership in the delivery of regulatory intelligence research services and information

  • Collaborating on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with more senior leaders

  • Managing more complex intelligence query requests from internal stakeholders

  • Serving as the functional lead on cross-functional organizational level projects or initiatives in supporting of GxP compliance or requirements

This role might be for you if can:

  • Lead junior team members in the following areas:

  • Monitor and analyze the external regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders

  • Monitor and analyze global regulatory intelligence sources for the most current changes and information in the drug development space

  • Assess regulatory intelligence information for relevance and impact to companys internal processes, drug development projects and/or regulatory strategies

  • Identify business critical aspects and communicate effectively to internal stakeholders

  • Support project teams, functions and departments through the collection and distribution of requested regulatory intelligence information.

  • Provide regulatory intelligence in support of a range of operational study design and operational planning activities. This includes regular updates on new information that could impact clinical trial execution as well as ad hoc requests to input into feasibility.

  • Produce regulatory intelligence reports or deliverables as it relates to project or process strategies

  • Collaborate with cross-functional team from preclinical to commercial to identify and assess key regulatory requirements, regulations, guidance, and information

  • Synthesize information from global requirements database as well as interaction with local country experts as needed

  • Share/Input data into systems or tools to enable effective knowledge management of country level operational intelligence data.

  • Conduct the initial analysis of commenting opportunities and assist with drafting of comments for submission to industry organizations, Health Authorities and other stakeholders

  • Facilitate regulatory intelligence review meetings and/or lunch-n-learn sessions

  • Collection and maintenance of regulatory intelligence newsletter content and distribution to organization

  • Manage content of and updates to the Regulatory Intelligence SharePoint and intranet sites

  • May have direct reports or mentor junior team member(s)

To be considered for this opportunity, you must have the following:

  • Advanced life science degree or related field

  • Minimum of 6 years experience in the biotech/pharmaceutical industry with a strong focus in Regulatory Intelligence

  • Good understanding of the drug development and commercialization process, with a focus on clinical development and trial execution

  • Experienced in understanding and interpreting regulatory guidelines and documents

  • Ability to research, analyze and extrapolate critical regulatory information, with a focus on clinical requirements and recommendations

  • Highly organized and able to work independently to meet deliverable on time and on target

  • Team-oriented and strong relationship builder, ability to effectively collaborate with a range of individuals across the organization at all level

  • Attentive to details and focused on quality output

  • Effective communicator - - both written and oral in a multi-discipline team environment.

  • Proficient in the navigation of intelligence database(s)

  • Prior experience in Clinical Trial Operations

  • Basic knowledge in the monitoring and sourcing of regulatory requirements information in pharmaceutical industry

Please note, this role requires you to work 3 days onsite weekly out of our New York or New Jersey offices. If you are not local and qualify, we can offer a relocation package!

#GDRAJobs #GDPSJobs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$129,800.00 - $211,800.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
US

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